FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Chemistry ×
13,237 results
9697–9720 of 13,237
Search insights Median review: 56d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: Chemistry
Cleared Sep 28, 1984
TITAN GEL ISO DOT CPK PROCEDURE
K842755 · CGS
Helena Laboratories
Chemistry · 74d
Cleared Sep 28, 1984
ENZYMATIC CHOLESTEROL KIT
K843222 · CHH
Livonia Diagnostics, Inc.
Chemistry · 43d
Cleared Sep 28, 1984
CREATININE ASSAY KIT
K843377 · CGX
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 28, 1984
VMA ASSAY KIT
K843379 · CDF
Diagnostic Chemicals, Ltd. (Usa)
Chemistry · 31d
Cleared Sep 28, 1984
LEECO CORTISOL-QUANT
K843384 · CGR
Leeco Diagnostics, Inc.
Chemistry · 31d
Cleared Sep 28, 1984
PDA CHOLESTEROL
K843510 · CHH
Abbott Laboratories
Chemistry · 22d
Cleared Sep 28, 1984
GLUCOSE OXIDASE ENZYMATIC REAGENT SET
K843528 · CGA
Livonia Diagnostics, Inc.
Chemistry · 21d
Cleared Sep 28, 1984
PDA GLUCOSE
K843541 · CFR
Abbott Laboratories
Chemistry · 21d
Cleared Sep 28, 1984
PRECISET AMMONIA
K843569 · JJX
Boehringer Mannheim Corp.
Chemistry · 18d
Cleared Sep 28, 1984
QUALIFY I & II AMER. MONITOR 2009 & 2010
K843611 · JJY
American Monitor Corp.
Chemistry · 15d
Cleared Sep 28, 1984
FIAX 420 DILUTOR
K843621 · JQW
Intl. Diagnostic Technology
Chemistry · 14d
Cleared Sep 28, 1984
MATCHED COMPONENT SET FOR RADIOIMMUNO-
K843635 · JKC
Cambridge Medical Technology
Chemistry · 11d
Cleared Sep 28, 1984
SYSTEMATE A AMYLASE HEM 67204
K843645 · CIJ
Em Diagnostic Systems, Inc.
Chemistry · 11d
Cleared Sep 27, 1984
ANDROSTENEDIONE BY RIA
K842960 · CIZ
Radioassay Systems Laboratories, Inc.
Chemistry · 62d
Cleared Sep 27, 1984
ISO-DATA IMMUNOASSAY NETWORK SYSTEM
K843365 · JQP
Iso-Data, Inc.
Chemistry · 30d
Cleared Sep 27, 1984
STANDARD & SOLUTIONS FOR NOVA 4 ANALYZ
K843452 · JGS
Fisher Scientific Co., LLC
Chemistry · 22d
Cleared Sep 26, 1984
ACCUSCREEN TSH
K843281 · JLW
Neometrics, Inc.
Chemistry · 37d
Cleared Sep 26, 1984
ULTRAVIOLET-VISIBLE SPECTROPHOTOMETER
K843460 · JJQ
Varian Assoc., Inc.
Chemistry · 21d
Cleared Sep 26, 1984
TRIGLYCERIDES GPO REAGENT
K843552 · CDT
Bio-Rad
Chemistry · 16d
Cleared Sep 21, 1984
STANBIO QUICK-TELL MONOCLONAL INDIRECT
K842544 · JHJ
Stanbio Laboratory
Chemistry · 81d
Cleared Sep 21, 1984
PRECISION DISPENSER
K843606 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 21, 1984
LABOPETTOR
K843607 · JQW
Medical Technomics, Ltd.
Chemistry · 8d
Cleared Sep 20, 1984
SYSTEMATE T-BILI 67212
K843328 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d
Cleared Sep 20, 1984
SYSTEMATE D-BILI 67213
K843329 · CIG
Em Diagnostic Systems, Inc.
Chemistry · 24d